BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4182513 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36370
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED AN UNKNOWN SYSTEM ERROR ALARM. THE DEVICE WAS RETURNED TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION. AN EVENT HISTORY LOG REVIEW WAS PERFORMED, AND THE REPORTED PROBLEM WAS NOT VERIFIED AS ALL THE LOGS HAD BEEN ERASED DUE TO A DEPLETED BATTERY ON THE DIGITAL PCB. AN EXTERNAL AND INTERNAL VISUAL INSPECTION WAS PERFORMED AND FOUND A DETACHED INNER DOOR GASKET. THE DEVICE POWERED UP, BUT SYSTEM ERROR 2364 OCCURRED, WHICH WAS DUE TO DEPLETED BATTERY ON THE DIGITAL PCB. AFTER REPLACING THE DIGITAL PCB, A ONE-HOUR SIMULATED THERAPY WAS COMPLETED AND NO ERRORS OCCURRED. A SERVICE HISTORY REVIEW DID NOT FIND ANY SERVICE EVENTS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED PROBLEM. UPON COMPLETION OF THE INVESTIGATION, THE DIRECT CAUSE OF THE REPORTED PROBLEM WAS IDENTIFIED TO BE THE LITHIUM BATTERY ON THE DIGITAL PCB. THE DIGITAL PCB WAS REPLACED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED AN UNKNOWN ALARM. THIS OCCURRED DURING AN UNKNOWN STEP IN PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661114 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1